The MediBeacon^® TGFR is not approved for use in patients with GFR <15ml/min/1.73m², GFR >120ml/min/1.73m², patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).

The MediBeacon^® TGFR Disposable Ring and the exogenous tracer agent, Lumitrace^® injection, are single use and are only used with the MediBeacon^® TGFR.

The MediBeacon^® TGFR Disposable Ring is intended to be assembled with the MediBeacon^® TGFR Reusable Sensor and attaches to the patient’s skin during a TGFR session.

The MediBeacon^® TGFR Reusable Sensor is intended to excite fluorescence in Lumitrace^® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon^® TGFR Monitor.

Lumitrace^® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon^® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment.

Contraindication:
There are no known contraindications.

Warnings and Precautions:

• See ifu.medibeacon.com for full instructions, warnings, and cautions.
• In clinical studies no serious or severe adverse events have been observed.
• Lumitrace^® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace.
• Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally impaired patients).
• Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established.
• During a TGFR session, the patient should be as still as possible, especially during the “Establishing Baseline” stage. The system is designed to compensate for light activity such as reading or eating after the Baseline stage.
• A linear regression analysis found that the mean of the difference tGFR – nGFR tended to decrease by -0.37 mL/min/1.73m² per year increase in age after adjustment for nGFR, Sex, Race and Fitzpatrick skin scale, which all had insignificant effects. For example, a 10-year increase in age will tend to decrease the difference by 3.7 mL/min/1.73m².
• In the study tGFR tended to underestimate nGFR (mean difference -5.3, 95% CI -7.8, -2.9). For example, if the nGFR reports a GFR value of 30 ml/min/1.73m², then the tGFR value was on average about 25 ml/min/1.73m².